Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors

Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455584

Enrollment

Registered

2011-10-20

Start date

2011-06-30

Completion date

2013-05-31

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies

Keywords

HM781-36B

Brief summary

The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

Detailed description

Besides the main objective, there are 4 other objectives as follows: 1. To determine dose-limiting toxicity (DLT) of HM781-36B 2. To determine Maximum Tolerated Dose (MTD) of HM781-36B 3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously 4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Interventions

DRUGHM781-36B tablets

Q1X28D/4W for HM781-36B tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or cytologically confirmed advanced solid tumor 2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3. Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved 4. Aged ≥19 5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 6. A life expectancy greater than 12 weeks 7. Adequate bone marrow, renal and liver function. 8. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion criteria

1. Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis. 2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3. Patients who have GI malabsorption or difficulty taking oral medication 4. Patients who have psychiatric or congenital disorder 5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Design outcomes

Primary

Measure	Time frame
MTD determination	Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026